NCT04611529

Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Ibuprofen 400 mg	Ibuprofen 400mg
DRUG	Topical diclofenac	Diclofenac 1% gel 4gm

Timeline

• Start date: 2021-03-02
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-11-02
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study